MasimoSET® LNCS® Inf Infant Pulse Oximeter Adhesive Sensor 2319Recalls & reported problems
Masimo Corporation · MasimoSET LNCS Inf Infant Pulse Oximeter Adhesive Sensor · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10843997000885), received between Aug 9, 2017 and Aug 11, 2017 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Device Alarm System” (2 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Device Alarm System2
- Device Operates Differently Than Expected2
- Device Stops Intermittently2
Patient problems
- No Consequences Or Impact To Patient4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 11, 2017Device Stops Intermittently; Device Stops Intermittently
THE CUSTOMER REPORTED THE PROBE STOPPED WORKING INT THE MIDDLE OF AN OPERATING ROOM (OR) CASE. NO PATIENT IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6790501 ↗MalfunctionAug 11, 2017Device Stops Intermittently; Device Stops Intermittently
THE CUSTOMER REPORTED THE PROBE STOPPED WORKING INT THE MIDDLE OF AN OR CASE. NO PATIENT IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6790247 ↗MalfunctionAug 9, 2017Device Alarm System; Device Operates Differently Than Expected; Device Alarm System; Device Operates Differently Than Expected
THE CUSTOMER REPORTED THE FOLLOWING ISSUE: "IF THE PROBE GOES BAD (WE HAVE HAD A FEW), THERE IS NO ALARM, THE PATIENT IS THEN HOOKED UP WITH NO SATS ON THE MONITOR." NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6778949 ↗MalfunctionAug 9, 2017Device Alarm System; Device Operates Differently Than Expected; Device Alarm System; Device Operates Differently Than Expected
THE CUSTOMER REPORTED THE FOLLOWING ISSUE: "IF THE PROBE GOES BAD (WE HAVE HAD A FEW), THERE IS NO ALARM, THE PATIENT IS THEN HOOKED UP WITH NO SATS ON THE MONITOR." NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6778945 ↗
Other Oximeter devices
- Trilogy Trilogy100 Ventilator, InternationalRespironics, Inc. · Oximeter8 deaths2,493 reports
- Trilogy Trilogy 202 Ventilator, United StatesRespironics, Inc. · Oximeter2 deaths1,594 reports
- HAMILTON-G5 159001Hamilton Medical AG · Oximeter18 deaths1,440 reports
- Trilogy Trilogy100 Ventilator, GermanyRespironics, Inc. · Oximeter696 reports
- Model EMV+ Vent, Army, MRI 799-EMVP-04Zoll Medical Corporation · Oximeter1 death605 reports
- Trilogy Evo, O2, Japan JP2100X16BRespironics, Inc. · Oximeter4 recalls5 deaths342 reports
- Model EMV+ Vent, Army, COMMERCIAL 799-EMVP-01-01Zoll Medical Corporation · Oximeter1 death497 reports
- HAMILTON-G5 159002Hamilton Medical AG · Oximeter3 deaths451 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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